Advancing Joint Care Worldwide: HYMOVIS® ONE Receives FDA Approval

Fidia expands its portfolio of therapeutic solutions with the FDA approval of HYMOVIS® ONE, an innovative single injection hyaluronan therapy for knee osteoarthritis

Fidia Farmaceutici announces an important milestone in the expansion of its global therapeutic offering: the U.S. Food and Drug Administration (FDA) has approved HYMOVIS® ONE, a pioneering hyaluronic acid (HA)-based intra-articular therapy for the treatment of pain in knee osteoarthritis (OAin patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics.

Already commercially available across multiple European markets, HYMOVIS® ONE now enters the U.S. as the first and only non-crosslinked, non-avian (bacterially fermented) single-injection HA viscoelastic hydrogel for OA knee pain relief.

A significant step in widening Fidia’s therapeutic solutions

The FDA’s approval of HYMOVIS® ONE marks a strategic advancement in Fidia’s   commitment to broaden its global portfolio of high value treatments for musculoskeletal diseases.  By granting market authorization, the Agency confirms that the evidence generated throughout development meets its stringent regulatory standards for quality and robustness.

To achieve this milestone, the clinical program was fully aligned with FDA guidelines for new OA product development and was closely overseen by Fidia’s R&D team, supported by the expertise and coordinated contribution of multiple departments, whose combined efforts made this result possible. The study progressed according to plan, with no delays, and delivered strong, consistent results across all parameters. In a clinical pivotal study, HYMOVIS^® ONE delivered clinically meaningful and effective improvements in pain and function for patients with OA knee pain, with no pseudoseptic reactions and no serious adverse events, at 12-weeks (3 months) and 26-weeks (6 months).¹

A global milestone for patients and partners

With this approval, HYMOVIS® ONE strengthens Fidia’s global position in HA treatments and reinforces the company’s commitment to delivering the first and only non-crosslinked, non-avian (bacterially fermented) single-injection HA viscoelastic hydrogel for OA knee pain relief available on the US market. The U.S. launch complements the product’s established presence in Europe and supports Fidia’s strategy to provide innovative, evidence-based therapies ranging from hyaluronic acid injections to the most advanced approaches across international markets.

References:

1. HYMOVIS^® ONE Summary of Safety and Effectiveness Data (SSED) P150010/S005